Quality & Risk
Use Specification
In one line
Defined description of intended users, uses, use environments, and patient populations for a device.
Definition
Per IEC 62366-1, the use specification documents the intended medical indication, patient population, intended part of the body or tissue, intended user profile, intended use environment, and operating principle.
The use specification is the starting point for usability engineering: it defines who uses the device, where and how, which drives user interface design, task analysis and the selection of participants for formative and summative evaluations. FDA human factors guidance asks for similar information on intended users, uses and use environments. It should be consistent with the intended use and labeling.
Why it matters
Drives the use-related risk analysis and human factors validation. Discrepancies between use specification and real-world clinical use are a frequent root cause of use errors.
Common pitfalls
- •Failing to involve actual users in the development of the use specification can lead to an incomplete or inaccurate understanding of real-world use conditions.
- •Not updating the use specification throughout the device lifecycle, especially after design changes or new clinical insights, can introduce significant risks.
- •Confusing the use specification with marketing claims can result in a document that exaggerates capabilities or misrepresents the intended user base.
- •An overly broad or vague use specification can make it difficult to conduct a thorough use-related risk analysis and human factors validation.
- •Disregarding the influence of the use environment on user interaction and device performance is a common oversight that leads to use errors.
Sources
- IEC 62366-1 · IEC
- ISO 13485 Standard Page · ISO
- AAMI - Quality Systems Resources · AAMI